FINAL DRAFT prEN 14931

prEN 14931:2006 (E)
Annex B
(informative)
Recommendations for medical devices used in hyperbaric chamber systems
B.1 General
This annex refers to medical devices defined as any item of equipment required for the treatment of the patient,
introduced punctually in the hyperbaric chamber and not concerned by this European Standard.
This annex describes:
⎯
⎯
⎯
the potential hazards which certain medical devices represent;
the risks induced by medical devices likely to be used within hyperbaric chamber systems intended for
hyperbaric oxygen therapy;
the recommendations for manufacturers of medical devices and users of hyperbaric chamber systems, in order
to achieve the highest possible level of safety of the patient and the attendants.
B.2 Pressure
B.2.1 Potential hazard
A hyperbaric chamber realises an environment where the internal pressure is increased over the atmospheric
pressure.
B.2.2 Risk
Certain medical devices, designed and manufactured for use at atmospheric pressure, cannot be used under
hyperbaric conditions. Indeed, their introduction into a hyperbaric chamber can give rise to several types of
problems:
⎯
⎯
crushing, implosion or explosion of certain components under the effect of the variation in pressure, together
with, as secondary effects, risks of failure, of short circuits, of formation of sparks, of overflowing, projection of
fragments or of liquids;
a modification of the rated performances of the device with in particular:
⎯
⎯
⎯
⎯
a deterioration of the measurements recorded by the probes;
a deterioration of the display reading which no longer corresponds to the measured values;
a deterioration of the flowrate, pressure and frequency with which the device dispenses the medical
products to the patients;
a possible creation of gaseous bubbles at time of decompression within the liquids contained in, or
conveyed by, the medical device.
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